Exploring the Effect of the Transcendental Meditation® Technique on Migraine Frequency and Functionality: A Single Arm Study

NCT06695156 | Active Not Recruiting

• 1 other identifier: MIU002
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This research will explore the effect of the Transcendental Meditation® Technique on migraine intensity and frequency. It will be a single-arm pilot study involving 30 participants recruited from migraine treatment facilities and support groups in the US.

Conditions

Migraine; Migraine With or Without Aura

Keywords

Migraine; Meditation; Transcendental Meditation

Outcome Measures

Primary Outcomes (4)

• Frequency and functionality

  Frequency and functionality will be measured by the data recorded in the migraine App.

  6 Months

• The Migraine Disability Assessment (MIDAS) to measure frequency and functionality.

  6 Months

• Migraine Specific Quality of Life Questionnaire (MSQ), version 2.1 to measure impact on Quality of Life

  6 Months

• Questionnaire (MSQ), version 2.1 to measure impact on functionality.

  6 months

Study Arms (1)

Exploring the Effect of the Transcendental Meditation® Technique on Migraine

EXPERIMENTAL

Behavioral: Meditation

Interventions

Meditation BEHAVIORAL

The objective of this study is to assess the safety, feasibility, and effects of the practice of the Transcendental Meditation technique in adults with migraines. This study will involve 30 male and female participants recruited from migraine treatment facilities and migraine support groups in the US. The study will span three months, with all participants practicing Transcendental Meditation (TM) while continuing their usual lifestyle and medication regimen. Pre-data will be collected through symptom analysis, headache patterns, and evaluation questionnaires. All potential subjects will use a migraine App for 30 days prior to inclusion in the study, both as a means of assessing migraine status and of ability to adhere to study protocols during the study. In addition, all subjects will take the PHQ-9 to screen for levels of depression that might impair participation in the study. All the subjects will receive TM instruction, followed by bi-weekly

Exploring the Effect of the Transcendental Meditation® Technique on Migraine

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Diagnosis of migraine with or without aura, based on ICHD3 criteria
• migraine days/month.
• ≥ one-year history of migraines starting before the age of 50.
• ≥ 18 years old or ≤ 60 Years old
• Willing to attend follow-up sessions.
• Willing to practice TM twice a day for 20 minutes.
• Fluent in English.
• Willing to continue the same medication without any additional medicine
• In good general health, with no other diseases expected to interfere with the study.

You may not qualify if:

• \> 60 years old or \< 18 Years old
• Already practicing Transcendental Meditation.
• Pre-diagnosed major systemic illness or unstable medical/psychiatric condition (eg, suicide risk) requiring immediate treatment or that could compromise protocol adherence
• Medication overuse headache (MOH)
• Current/planned pregnancy or breastfeeding
• New prophylactic migraine medicine started within 4 weeks of the screening visit
• Unwilling to maintain stable migraine medication dosages
• Failure to complete baseline headache logs.

Sponsors & Collaborators

• Maharishi International University: lead

Study Sites (1)

Georgetown Headache Center and DC area

Washington D.C., District of Columbia, 20036, United States

Location

Related Links

• Migraines and Meditation We are conducting research to see the effect of Transcendental Meditation (TM) on the intensity and frequency of migraines.

MeSH Terms

Conditions

Migraine Disorders

Interventions

Meditation

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies; Relaxation Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Dr. Fred T Travis, PhD

  Maharishi International University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Brain Center and PhD Chair of the Department of Maharishi Vedic Science at Maharishi University of Management

Model Details: It is a pilot study investigating the impact of Transcendental Meditation on migraine as a basis for a larger randomized control study.

Study Record Dates

• First Submitted: November 2, 2024
• First Posted: November 19, 2024
• Study Start: August 28, 2024
• Primary Completion: April 30, 2026
• Study Completion: May 1, 2026
• Last Updated: November 6, 2025

Record last verified: 2025-08

Locations

US (1)